Data Systems QA and Compliance Leader

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Takeda Development Center Americas, Inc. is seeking a Data Systems QA and Compliance Leader in Lexington, MA with the following requirements: Bachelor's degree in Pharmacy or related field plus 4 years of related experience. Prior experience must include: Perform analytical method development (HPLC, UPLC) using reversed phase chromatography (RP) in regulated environment (GxP/GLP) using Agilent ChemStation and Waters Empower 2 and 3 Chromatography Data System (CDS) and drafting SOPs (procedures) thereof; draft and execute Computerized Systems Validation (CSV) for analytical instruments (ICP-MS, DSC,) and enterprise systems (Empower) in accordance with electronic records and electronic signatures regulations, including 21 CFR Part 11; author site-wide Standard Operating Procedures (SOPs) for calibration, preventative maintenance, and operation of agilent High Performance Liquid Chromatography (HPLC and UPLC) 1100/1260/1290 Systems using Waters Empower and Agilent Chemstation in regulated GLP environment; develop analytical and enterprise systems qualification protocols (including design, installation, operation and performance qualifications, risk assessment, validation plan, user requirements, functional requirement, traceability matrix) under GAMP (Good Automated Manufacturing Practice), electronic records and electronic signatures principles (21 CFR Part 11 and Annex 11) in commercial GMP environment; troubleshoot, root-cause analyze, and resolve issues with deviations and out-of-specification (OOS) analytical instruments (chromatography, spectroscopy), infrastructure (Environmental monitoring, HVAC, stability chambers, vaults, freezers, fridges) and continuing qualification (Temperature Mapping) and resolution of issues thereof in Corrective Action/Preventative Action Plans (CAPAs)/Effectiveness Checks (EC) while communicating to multidisciplinary teams, in commercial GMP environment; perform calibration and preventative maintenance on analytical instruments (Karl Fisher, Balances, pH meters, disintegrator, dissolution baths, UV/VIS, FTIR, HPLC, GC, Dataloggers) and laboratory computerized systems (including Empower CDS, Rotronic EMS, Kaye LabWatch) in Commercial cGMP; draft responses to regulatory agencies queries including observations/483s and action plans based on the state of the art and regulations in the field (Temperature/Humidity Mapping and Monitoring guidance from WHO, ISPE, USP, FDA, PDA). Up to 20% domestic & international travel required for R&D quality functions and activities.

Full time. $177,500 - $186,000 per year.

Apply on-line at https://jobs.takeda.com and search for Req #R0132042.